MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number MAJ-1517

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Dung examination, a translucent foreign object was found in the resin part of the connector.Dimensional inspection of the device found that the device met with specifications after the foreign object was removed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported to olympus that the connecting tube used during scope cleaning had a connector end that was so small it was impossible to check.When comparing to similar products, the customer found the holes of the product were clearly smaller.During use of the connecting tube, the customer could not visually check whether water pressure was being applied properly.The connecting tube is only used for scope reprocessing.No patient involvement reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the foreign material remained due to reprocessing being deviated from the instruction manual.The foreign material appears to be glue.The event can be prevented by following the instructions for use (ifu) which state: "¿maj-1517 instruction manual¿ 7 preparation and inspection warning over time, the connecting tube will deteriorate because it is subject to wear with each use.If any of the following are found with the connecting tube, do not use it and replace it with a new one.¿oer-5 operation manual¿ 4.8 reprocessing 3.A jet of water is output from the hole on the connecting tube during reprocessing.Make sure that the water hits the lid (check that there is no clogging or irregularity of the channels inside the equipment)." olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Type of Device: ENDOSCOPE REPROCESSOR ACCESSORIES
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18373300
• MDR Text Key: 331111194
• Report Number: 9610595-2023-20087
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170234064
• UDI-Public: 04953170234064
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1